Letters to Government Officials
Letter to Dr. Woodcock, FDA Director for the Center for Drug Evaluation and Research on the approval of Qnexa, a weight-loss drug
In this letter, NRC and other women's organizations urge the FDA to not approve Qnexa, a weight loss drug, because of serious unresolved safety concerns about its potential to cause cardiovascular harm and birth defects. | more
NRC Comment on a FDA Guidance on the Evaluation of Sex Differences in Medical Device Clinical Studies
The National Research Center for Women and Families has been a long-time advocate of medical device clinical studies including data on safety and effectiveness for women. In this comment letter to the FDA, we describe the importance of analyzing data for women separately and how this information should be used to help women and providers make the best informed decisions. | more
Letter to Dr. Hamburg, FDA Commissioner on the Review of Drospirenone (DRSP)-based Oral Contraceptives
March 9, 2012 Margaret Hamburg, M.D. Commissioner Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993-0002 Re: FDA Review of Drospirenone (DRSP)-based Oral Contraceptives Dear Commissioner Hamburg: We are writing to follow up on our meeting with you in December and to express our strong concerns about the December 8, 2011 FDA joint meeting of the Advisory Committee for Reproductive Health [...] | more
Letter from the Patient, Consumer and Public Health Coalition to Dr. Margaret Hamburg on the De Novo Process and High-Risk Medical Devices
February 28, 2012. In this letter to the FDA Commissioner, the Patient, Consumer, and Public Health Coalition expresses their concerns over the de novo approval process for high-risk medical devices, specifically a endovascular suturing system. | more
FDA Needs to Provide Breast Implant Patients and Physicians with Unreported Industry Data about Quality of Life, Connective Tissue Symptoms, Rupture Rates per Patient, and Other Complications
January 5, 2012 Dr. Jeffrey Shuren, Director Center for Devices and Radiological Health Food and Drug Administration Silver Spring, MD 20993 RE: FDA Needs to Provide Breast Implant Patients and Physicians with Unreported Industry Data about Quality of Life, Connective Tissue Symptoms, Rupture Rates per Patient, and Other Complications Dear Dr. Shuren: At the FDA Advisory Panel meetings in 2003 [...] | more
Letter to Dr. Margaret Hamburg, FDA Commissioner, about maintaining and strengthening conflict of interest policies for advisory committees
In this letter to FDA Commissioner, Dr. Margaret Hamburg, NRC and other coalition members advocate for stronger conflict of interest requirements for members of FDA advisory committees to protect patients and consumers against industry biases. | more
Keeping Safeguards That Protect Our Health
NRC signs on to a letter opposing the Regulatory Accountability Act (RAA) (H.R. 3010/S. 1606) and the Regulations from the Executive in Need of Scrutiny (REINS) Act of 2011 (H.R. 10/S. 299) to protect a safe food supply, clean air and water, and a variety of consumer protections for American families. | more
Letter from the Patient, Consumer, and Public Health Coalition to Jeffrey Shuren, Director, Center for Devices and Radiological Health (FDA), about improving medical device safety
January 18, 2011 | more
Comments to FDA on Medical Device User Fees (MDUFA)
November 1, 2010 | more
